* U.S. advisory panel had recommended drug's use
* Afinitor seen as future blockbuster
ZURICH, May 6 Novartis AG's NOVN.VX (NVS.N)
cancer drug Afinitor has been approved by the U.S. Food and Drug
Administration for a rare type of pancreatic cancer that has few
"Data show Afinitor delays tumour growth and reduces risk of
disease progression in patients with advanced neuroendocrine
tumours (NET) of pancreatic origin," the Swiss drugmaker said in
"This marks the first approval of a treatment for this
patient population in the United States in nearly 30 years."
Last month, a U.S. advisory panel voted unanimously in
favour of the drug's use in treating patients with advanced
pancreatic neuroendocrine tumours, despite concerns about
serious side effects. [ID:nN12179016]
Afinitor is already approved for treating kidney cancer and
is expected to rake in sales of $1.3 billion in 2015, according
to a Thomson Reuters forecast.
In April FDA staff questioned Novartis' findings on the
benefits of the drug, and the Swiss drugmaker narrowed the
approval application after the reviewer's comments.
Novartis said it had also submitted applications for
Afinitor use for pancreatic cancer to the European Medicines
Agency and the Swiss regulator.
Pancreatic neuroendocrine tumours are rare, with a strike
rate of about 0.32 case per 100,000 people. They usually grow
more slowly than other pancreatic cancers that kill within
months of diagnosis. Both types have few treatment options.
(Reporting by Emma Thomasson; Editing by David Cowell)